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Simple brain scan could open lifesaving stroke treatment to millions worldwide

NCT ID NCT07001852

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This global study tests whether a procedure that removes blood clots from the brain can safely help stroke patients treated up to 72 hours after symptoms start, using only a basic CT scan that is available in most hospitals. Currently, this treatment is only proven within 6 hours or with advanced imaging that many hospitals lack. The trial will enroll 500 adults aged 18 to 80 with moderate to severe stroke and a large vessel blockage. Participants will either receive standard medical care or that plus the clot-removal procedure. The goal is to see if the procedure leads to better recovery at 90 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Endovascular therapy (mechanical thrombectomy) using a catheter to remove blood clots from brain arteries
What this could lead to
If successful, this could allow more stroke patients, especially in rural or under-resourced hospitals, to receive clot-removing treatment up to 72 hours after symptoms start, improving recovery and reducing long-term disability.
What could go wrong
This is a phase 3 trial, but it is still recruiting and results are not yet known. The simpler CT-based selection method may not identify the right patients as accurately as advanced imaging, and the procedure carries risks like brain bleeding.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 18 to 80 years of age: 1. Pre-stroke score (mRS) of 0-1 in participants aged 18 to 70 years. 2. Pre-stroke Modified Rankin Scale (mRS) score of 0 in participants older than 70 years. 2. Presenting with signs and symptoms consistent with an acute ischemic stroke within 24-72 hours from last known well. \* 3. Baseline NIHSS ≥8. 4. NCCT imaging indicating the existence of an anterior circulation LVO by an automated software, or CTA (when available). 5. Core volume ≤ 70 cc determined by a deep learning algorithm in automated software and/or ASPECTS scoring ≥ 6. \*\* 6. Arterial puncture within 72 hours (after the first symptoms or LKW). 7. Arterial puncture within 90 minutes from initial CT. 8. Ability to randomize within 72 hours after stroke onset (last seen well). 9. Ability to obtain signed informed consent or subject's Legally Authorized representative (LAR) has signed Consent form \*\*\* * Patients in the 6-24-hour after Last Known Well (LKW) may be enrolled only in centers where thrombectomy is not offered as standard of care due to the absence of advanced imaging capabilities. * In cases of discrepancy between the automated tool LVO detection and volume, and ASPECT Score or CTA judgment or Computed Tomography Angiography CTA findings, ASPECTS and CTA will take precedence. * If approved by local ethics committee and country regulations, the investigator is allowed to enroll a patient utilizing emergency informed consent procedures if neither the patient nor the representative or person of trust is available to sign the informed consent form. However, as soon as possible, the patient is informed, and his/her consent is requested for the possible continuation of this research. Exclusion Criteria: 1. Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test. 2. Known severe allergy (more than a rash) to contrast media uncontrolled by medications. 3. Refractory hypertension (defined as persistent systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg) despite medication. 4. CT evidence of the following conditions: * Midline shift or herniation. * Evidence of intracranial hemorrhage. * Mass effect with effacement of the ventricles. 5. Bilateral strokes. 6. Clot retrieval previously attempted \<6 hours. 7. Treated with thrombolytics \>4.5 hours after last seen well. 8. Intracranial tumors. 9. Life expectancy less than 90 days prior to stroke onset. 10. Participation in another randomized clinical trial that could confound the evaluation of the study. 11. Presumed septic embolus, or suspicion of bacterial endocarditis. 12. Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia with prescribed anti-cholinesterase inhibitor (e.g. Aricept). 13. Any other condition (in the opinion of the site investigator) that precludes an endovascular procedure or poses a significant hazard to the patient if an endovascular procedure was performed.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Erebouni Medical Center

    RECRUITING

    Yerevan, Armenia

  • University of Iowa

    NOT_YET_RECRUITING

    Iowa City, Iowa, 52242, United States

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